MANHATTAN — A federal district court judge in New York has ordered the U.S. Food and Drug Administration (FDA) to move forward with its 1977 promise to start proceedings addressing concerns over subtherapeutic use of antimicrobials in food animals.

United State Magistrate Judge Theodore H. Katz issued the ruling March 22 in the U.S. District Court for the Southern District of New York in response to a lawsuit filed in May 2011 by the Center for Science in the Public Interest (CSPI), National Resources Defense Council (NRDC), the Union of Concerned Scientists and Food Animal Concerns Trust.

The four organizations contend that the FDA shirked its responsibilities for more than 30 years by allowing low doses of antibiotics to be used for growth promotion in livestock.

The lawsuit points to notices filed by the FDA in 1977 that proposed proceedings to withdraw approvals for subtherapeutic uses of penicillin and tetracycline. About 20 drug firms requested hearings after the issuance of those notices, and the FDA commissioner granted requests for the hearings in 1978, adding that hearing dates would be set "as soon as practical." But hearing dates were never set, according to Katz's ruling.

Instead, the FDA has released a number of statements since 1977 about antibiotic use, including a 2010 guidance document that urged judicious use of medically important antimicrobials in food animals. The FDA also called for a phase-out of antimicrobial use for growth promotion in food animals.

In late 2011, the FDA withdrew the 1977 notices, saying they were outdated because a number of other measures are being taken by the agency to address concerns about antimicrobial resistance and the withdrawal process would be lengthy and expensive. Along with withdrawing the notices, the FDA denied two petitions filed by the CSPI—one in 1999 and one in 2005—calling for the phase-out of nonmedical antibiotic use in food animals.

The lawsuit that drew the March 22 ruling was filed over the FDA's failure to respond to those petitions, according to the CSPI and the NRDC.

Although the FDA argued that the withdrawal of the 1977 notices should make the lawsuit's complaint moot, Katz ruled that the plaintiffs are still entitled to relief if they can establish that the withdrawal of the 1977 notices did not rescind the FDA's findings that subtherapeutic use of penicillin and tetracyclines in animal feed is not demonstrably safe.

Because the FDA wrote in its 2011 withdrawal of the 1977 notices that it "remains concerned about the issue of antimicrobial resistance" despite the withdrawals and has published numerous studies to the same effect, Katz says the agency's continued concern about antimicrobial resistance is clear, despite withdrawing the decades-old notices.

In a statement released by the Animal Health Institute (AHI), the organization says the decision will needlessly divert time and resources from a collaborative stakeholder promise that is making headway.

"The decision by a district court judge ordering FDA to move forward with an administrative process on antibiotic use could unfortunately delay the process of eliminating the subtherapeutic (growth promotion) use of medically important antibiotics," the AHI says. "For more than two years FDA has clearly articulated its goal of eliminating subtherapeutic use and extending veterinary oversight using a collaborative, stakeholder process. That process is moving ahead. ... FDA has said the collaborative, stakeholder process is a more efficient way of achieving these goals than the process being forced by the court. It is unfortunate that time and resources will now be diverted to responding to the court decision."

NRDC attorney Jen Sorenson contends, "This health threat has been hiding in the margins for four decades. The rise of superbugs that we see now was predicted by FDA in the '70s. Thanks to the court's order, drug manufacturers will finally have to do what FDA should have made them do 35 years ago: prove that their drugs are safe for human health or take them off the market."

"Judge Katz's decision is an important advance toward our goal of preserving the effectiveness of medically important antibiotics and not squandering them with reckless overuse on animal farms," adds CSPI Executive Director Michael F. Jacobson. "Improving conditions for chickens, hogs and cattle would help obviate the reason these drugs have been overadministered in the first place."

Katz's order now requires the FDA to initiate withdrawal proceedings for relevant NADAs (new animal drug applications) and ANADAs (abbreviated new animal drug applications). More specifically, Katz says the FDA must reissue a notice of the proposed withdrawals, which may be updated, and provide opportunities for hearings to drug sponsors. A withdrawal order must follow the hearing if the drug sponsor is unable to prove the safety of the drug. If sponsors demonstrate that subtherapeutic uses of penicillin and tetracyclines in livestock are safe, then the FDA cannot withdraw approval, Katz says.

Both the FDA and the plaintiffs have requested additional clarification on a timeline for conducting the hearings and the issuance of final decisions, according to court records.

The American Veterinary Medical Association (AVMA) announced a partnership with the FDA last summer and pledged to create a steering committee to provide veterinary input to federal regulators charged with crafting new antimicrobial use guidelines.

"The AVMA acknowledges the growing concern regarding antimicrobial use and resistance in animals and people, and supports the judicious use of antimicrobials to maximize public and animal health benefits while minimizing risks," says AVMA Chief Executive Officer Dr. Ron DeHaven. "The judicious use of antimicrobials plays a key role in preserving the health of our nation's food animals and the safety of our nation's food supply. Many agree that there is a need for greater veterinary oversight of antimicrobial use in food-producing animals, and the AVMA is currently working with the FDA to develop practical means to increase this veterinary oversight."

But DeHaven cautions the withdrawal of approval or a ban on any antimicrobial uses should be based on solid science and risk-based assessment, not on anecdotal reports and speculation.

"It is crucial that safe and effective antimicrobials remain available for use in veterinary medicine to ensure the health and welfare of animals and, consequently, the health of humans," DeHaven adds. "The AVMA will continue to work closely with the FDA to formulate a sound, science-based strategy to deal with this complex issue."